FDA.reportPublic FDA data

RUSCH

Primary DI
04026704031849
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN050974
Catalog number
221800-000180
Device description
Bladder catether, Tiemann, 2 eyes
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZCCATHETER, COUDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704031843PackageGS150In Commercial Distribution
44026704031847PackageGS112Not in Commercial Distribution
04026704031849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670403184324026704031843
4402670403184744026704031847
04026704031849040267040318494026704031849

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; Keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23
14026704945846RUSCH2214000602214000602026-07-23
20801902193548ARROWIPN920133CS-15362-SPM2026-07-23
20801902193593ARROWIPN920138CS-15192-VF2026-07-23
14026704927453GIBECKIPN929805133122025-07-31
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704942456RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942463RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942470RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942487RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942494RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942500RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942517RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
10854913006195Urinary Catheter, 16 FrUROGEN PHARMA LTDEZC2025-11-17
10854913006157Urinary Catheter, 16 FrUROGEN PHARMA LTDEZC2025-11-16
10854913006119Urinary CatheterUROGEN PHARMA LTDEZC2022-06-01
10854913006126Urinary CatheterUROGEN PHARMA LTDEZC2022-06-01
10852141007731COMPACTCATH - LiteCOMPACTCATH, INC.EZC2019-09-01
00801741040665Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040672Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040689Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040696Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040702Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040719Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046520Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046537Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741017735Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741017742Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741017759Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741019333Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing CatheterC. R. Bard, Inc.EZC2016-08-06
00801741019340Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing CatheterC. R. Bard, Inc.EZC2016-08-06
00801741039096Bardia® Coude Olive Tip Urethral Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741039102Bardia® Coude Olive Tip Urethral Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040238Bard® Foley Catheter Tray With Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040252Bard® Urine Meter Foley Tray With Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040313Bard® Foley Tray with Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28